Most synthetic polymer membranes are extruded from the cornea after intralamellar implantation. This is explained by their impermeability, both to water and metabolites, which causes desiccation of the corneal stroma anterior to the membrane. It has been suggested that an approach to the problem of finding a suitable corneal implant material is the use of collagen.
Collagen is a protein which constitutes about 20 to 30 percent of the total body protein in vertebrates. It is a fibrous protein and functions primarily as a supporting tissue and scaffolding for other proteins and cells. It is present throughout the body but exists in high concentrations in skin, tendon and bone.
Collagen is recovered from these tissues by a variety of techniques, the oldest known method being the boiling of the tissue in water which denatures some of the collagen and forms gelatin on cooling. For use as a biomaterial however, collagen must be recovered in native, undenatured form, i.e., with little or no destruction of the basic rigid triple helical structure (tropocollagen).
Undenatured native collagen is recovered principally by two methods, (a) solution by dissolving the collagen in acids, bases, salts or by enzyme digestion, in which instances the collagen becomes actually dissolved, and (b) extraction in solid, undissolved, fiber form (hereinafter "fibrous collagen) usually by the action of aqueous salt or minced, comminuted collagen raw material to produce a dispersion from which the solid is recovered by centrifugation, etc. Both the solution and extraction methods are described in the collagen art.
Collagen materials have been studied for many years and for many suggested uses. For example, Dunn et al, in Science, 157 pp. 1329-30 (1967), the disclosure of which is incorporated herein by reference, describe the use of collagen-derived membranes for corneal implantation. Dunn et al, in Ophthalmic Surg., 2(1), pp. 9-11 (1971), the disclosure of which is incorporated herein by reference, described the use of collagen membranes for intralamellar corneal implants in experimental surgery. U.S. Pat. No. 4,268,131, the disclosure of which is incorporated herein by reference, describes a soft contact lens made from fibrous collagen and mixtures of such fiber with purified solubilized collagen. U.S. Pat. No. 4,223,984, the disclosure of which is incorporated herein by reference, describes soft contact lenses made from solubilized, defatted, cross-linked collagen, and/or chemically modified collagen. U.S. Pat. No. 4,164,559 describes a chemically modified membrane as a carrier for ophthalmic medication leaving no removable material after drug release. U.S. Pat. No. 4,233,360 describes a method for preparing non-mitigenic collagen and suggests its use for medical products such as sponges, prosthetic devices, films, membranes, sutures, etc. U.S. Pat. No. 4,279,812 describes a method for preparing macromolecular biologically active collagen and suggests its use for making implants for slow release of medication. See also Dunn et al., "Corneal Derived Membrane: Corneal Implantations," in Biomaterials, edited by Stark and Agarwal, Plenum Press, New York (1969) at pp. 195-199, the disclosure of which is incorporated herein by reference.
To date, no one to the knowledge of the present applicants has successfully produced a collagen material that can be used as a prosthetic replacement for the cornea. Typically collagen materials, although transparent when used in thin membranes, are not sufficiently transparent when made in a thickness suitable for use as a prosthetic replacement for the cornea.
Thus, there remains a desire for a native collagen material suitable for making a prosthetic replacement for the cornea.